Senior Project Manager - Medical Device Product Development
Novosound, a pioneering Glasgow-based ultrasound technology company, is seeking a Senior Project Manager to drive the commercialisation of their revolutionary blood pressure monitoring device - technology that could transform how we approach cardiovascular health monitoring globally.
This is your opportunity to join at a pivotal moment as they bring this groundbreaking innovation to market. You'll oversee the end-to-end product development of medical technology that will genuinely impact patient care, while working with advanced ultrasound technology in a fast-growing Scottish scale-up environment.
As Senior Project Manager, you'll guide the complete medical device lifecycle from concept through to commercialisation, managing design control processes under ISO 13485 QMS and navigating FDA regulatory pathways for US market entry. You'll coordinate multidisciplinary teams across R&D, Quality, Regulatory Affairs, and Manufacturing, ensuring full compliance with ISO 13485, ISO 14971, and 21 CFR Part 820.
What will you be doing?
* Lead end-to-end project management of novel medical device development
* Drive design control processes and create design history files
* Manage risk management activities per ISO 14971 and regulatory compliance
* Coordinate transfer to manufacturing, ensuring production readiness
* Support regulatory submissions
* Develop project schedules, budgets, and serve as central stakeholder contact point
To thrive in the role, you will have:
* Bachelor's degree in Engineering, Life Sciences, or related technical discipline
* Minimum 5 years' medical device project management experience
* Proven experience with ISO 13485 QMS and 21 CFR Part 820 compliance
* Strong background in design control activities and ISO 14971 risk management
* Hands-on experience with transfer to manufacture and medical device scaling
* Excellent communication, leadership, and stakeholder management skills
It'd be nice if you had:
* EU MDR, FDA 510(k) submissions and approvals experience
* Start-up or scale-up medical device environment background
* Project management certification (PMP, PRINCE2, AGILE)
* Experience with combination products or connected medical devices
What are the benefits?
* Competitive salary and comprehensive benefits package
* Opportunity to bring life-changing medical technology to market
* Work with pioneering ultrasound technology in a collaborative environment
* Professional development opportunities in a fast-paced growth company
Interested in taking things further?
If you'd like more information or to discuss your suitability, please apply now or contact me directly. All conversations are completely confidential.
Email: Richard.cross@edenscott.com
Please note that Eden Scott is working exclusively on this piece of recruitment and any CVs sent directly to Novosound from candidates or other agencies, will be sent to Eden Scott to manage.